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Active, Not Recruiting

NCT Number: NCT01888198

Ablation of Renal Masses Outcomes Registry (ARMOR): Ablation Procedure and Quality of Life Assessment

The purpose of this study is to better understand how effective ablation is for destroying tumor cells in the kidney and whether quality of life is improved for patients. Participation in ARMOR may involve retrospective data collection only, combined retrospective and prospective data collection, or prospective data collection

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Retrospective enrollment:

  • Patients having undergone percutaneous, open or laparoscopic energy ablation of a renal mass.

Prospective enrollment:

  • Patients scheduled to undergo, rather than having undergone, percutaneous, open or laparoscopic energy ablation of a renal mass.

Exclusion criteria

  • Patients not having undergone, or considered candidates for percutaneous, open or laparoscopic energy ablation of a renal mass
  • Non-English speaking patients
  • Patients under the age of 18.

Treatment and study plan

(EORTC QLQ-C30) questionnaire

Behavioral

Other names: European Organization for Research and Treatment of Cancer 30-item

EuroQol EQ-5D 7-item questionnaire

Behavioral

Primary outcomes

  1. assess renal ablation outcomes

    Time frame: 5 years

    To assess renal ablation outcomes using standard quality of life measures. Specifically, quality of life outcomes measures will be analyzed with respect to ablation procedure characteristics including ablation technique and anesthesia type as well as renal mass characteristics such as size, location and pathologic tumor type.

Secondary outcomes

  1. differences in imaging characteristics

    Time frame: 5 years

    between CT and MR related to renal ablation. We hypothesize that, after ablation, the observed relative change in contrast enhancement at the site of ablation for each follow-up time point will be similar for tumors imaged by CT compared with those imaged by MR. This objective will be met by observational and descriptive methods.

  2. Assess the progression of imaging findings

    Time frame: 5 years

    in terms of size and contrast enhancement at the site of renal ablation, correlated with ablation technology and tumor histopathology. The objective is to determine whether the choice of imaging method, ablation technique, or histopathologic tumor subtype will be associated with similar relative change in contrast enhancement and size after ablation.

  3. Radiation exposure

    Time frame: 5 years

    associated with CT imaging performed during an ablation procedure and subsequent imaging follow-up to 2 years. Radiation dose will be analyzed using multivariable linear regression, with ablation technique as the primary predictor.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Barbara Ann Karmanos Cancer Institute
  • Dartmouth-Hitchcock Medical Center
  • Hospital Sirio-Libanes
  • Icahn School of Medicine at Mount Sinai
  • M.D. Anderson Cancer Center
  • Rhode Island Hospital
  • San Diego Imaging Medical Group
  • Thomas Jefferson University
  • University Hospital, Bordeaux
  • University of California, Los Angeles
  • University of California, San Francisco
  • University of Maryland, Baltimore County

Registry information

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2013
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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